Language Development, Neurodevelopmental Outcomes, Premature Infant
Conditions
Brief summary
The purpose of this study is to adminster one of two education programs to parents of preterm infants in the NICU to evaluate language and cognitive outcomes of their infants.
Detailed description
The long term goal of this research is to determine the language environment necessary in the NICU for very preterm infants to optimize their long-term language and cognitive development. This study will pilot an early language intervention with parents of preterm infants in the NICU the purpose of which is to provide a structured curriculum for the family to guide their language interactions with their infant. The aim is to increase the adult word counts and conversational turns in the NICU and to improve Bayley III language and cognitive scores at 12 months and 24 months corrected age. The hypotheses is that increasing early language exposure in the NICU will result in improved lanugage and cognitive scores. The investigators plan on testing the hypothesis by the following specific aims. 1. Determine the effectiveness of a structured language curriculum with parents of preterm infants in the NICU on increasing the amount of early language exposure. 2. Test the the hypothesis that increased early language exposure will result in higher Bayley III language and cognitive scores.
Interventions
OTHERKnow Your Baby Language Curriculum
Early language activities that parents can do with their infants
OTHERReading Aloud Language Curriculum
Early language activity that parents can do with their infants
OTHERSing A Long Language Curriculum
Early language activity that parents can do with their infants
OTHERMimicking First Sounds Language Curriculum
Early language activity that parents can do with their infants
OTHERLanguage Games and Narrating Your Day Language Curriculum
Early language activity that parents can do with their infants
OTHERFeeding Safety
Part of Health and Safety Curriculum
OTHERCar Seat Safety
Part of Health and Safety Curriculum
OTHERBath Safety
Part of Health and Safety Curriculum
OTHERBack to Sleep/SIDS prevention
Part of Health and Safety Curriculum
OTHERTaking a Temperature and Signs of Infection
Part of Health and Safety Curriculum
OTHERInfection Control Measures and Vaccine Information
Part of Health and Safety Curriculum
Sponsors
Women and Infants Hospital of Rhode Island
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
23 Weeks to 32 Weeks
Healthy volunteers
No
Inclusion criteria
* Receiving care at Women & Infants' Hospital NICU, * Providence RI gestational age 23 - 32 weeks, * RI resident
Exclusion criteria
* Unable to understand or speak English, * congenital or chromosomal disorder likely to affect cognitive or speech development, * parental loss of custody
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bayley III cognitive composite score | 24 months | Bayley III cognitive score (mean 100, standard deviation 15) |
| Bayley III language composite score | 24 months | Bayley III Language score (mean 100, standard deviation 15) |
| Bayley III Expressive Language Score | 24 months | Bayley III Expressive Language (mean 10, standard deviation 3) |
| Bayley III Receptive Language Score | 24 months | Bayley III Receptive Language (mean 10, standard deviation 3) |
| Bayley III Motor Composite score | 24 months | Bayley III Motor composite score (mean 100, standard deviation 15) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Conversational turns Count | 32 weeks post menstrual age | LENA recordings of infant-parent conversational turns (softward derived recording of adult-child interactions that estimates the number of reciprocal vocalizations between infant and adult within 5 seconds, and recorded for a 16 hour time period). |
| Bayley III motor composite score | 12 month | Bayley III motor score (mean 100, standard deviation 15) |
| Bayley III receptive language score | 12 month (mean 10, standard deviation 3) | Bayley III receptive language score (mean 100, standard deviation 15) |
| Bayley III expressive language score | 12 month (mean 10, standard deviation 3) | Bayley III expressive language score (mean 100, standard deviation 15) |
| Adult word count Count | 32 weeks post menstrual age | LENA recordings of adult word count (softward derived number of adult words spoken during a 16 hour period). |
| Adult word count | 34 weeks post menstrual age | LENA recordings of adult word count (softward derived number of adult words spoken during a 16 hour period). |
| Bayley III cognitive composite score | 12 month | Bayley III cognitive score (mean 100, standard deviation 15) |
| Infant vocalizations Count | 32 weeks post menstrual age | LENA recordings of infant vocalizations (software derived recording of all speech related sounds recorded in a 16 hour time period). |
Countries
United States
Outcome results
None listed